Blog 4

Blog 4

Guidance
ICH Guidance M3 Nonclinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals

Status
This guidance was approved in June 2009.

Guidance Released
December 2009.

Link to Guidance
http://www.ema.europa.eu/pdfs/human/ich/028695en.pdf

Target Audience
This guidance is targeted for regulatory authorities, marketing authorization holders, and all parties responsible for non-clinical trial and all phases of clinical trial development. In addition to all those involved in the protecting public health.

Referenced Laws and Regulations
This guidance represents the European Medicines Agency non-clinical safety studies for the conduct of human clinical trials and marketing authorization for the pharmaceutical industry.

Summary
This guidance’s purpose is to recommend international standards and promote harmonization of non clinical safety studies that are recommended to support human clinical trials and marketing authorization for pharmaceuticals. Harmonization of the guidance for nonclinical safety studies helps to define current recommendations and reduce the likelihood of substantial differences amongst regions.

This guidance facilitates the timely conduct of clinical trials, reduces the use of animals in accordance with R3 (reduction, refinement, and replacement) principles and reduces the use of other drug development resources. In addition, promotes the development of safe, ethical, and availability of new pharmaceuticals.

Rationale
This document applies situations encountered during development of pharmaceuticals and should be viewed as general guidance for drug development. Nonclinical safety studies and human clinical trials should be planned and designed scientifically and ethically appropriate.

Recommendation
The recommendations of this revised guidance, is to harmonize nonclinical safety studies to support various stages of clinical development among regions of the European Union, Japan, and the United States.

Impact
Human clinical trials investigate the efficacy and safety of an investigational pharmaceutical product. Serious adverse event clinical or nonclinical findings influence decisions of continuing clinical trials. These findings should be reviewed to determine the appropriateness of the study design of additional nonclinical and/or clinical trials. As this impact the dose-range in nonclinical and clinical trials for a compound and whether the compound will move forward in development.